FDA applicant
Evolution Spine
FDA records 14 decisions for Evolution Spine (Dallas, TX) from 2016 to 2026: 14 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and OVE (Intervertebral Fusion Device With Integrated…). Since 2016 its 510(k)s took a median of 95 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 11 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Evolution Spine, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Evolution Spine’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Evolution Spine’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Evolution”
FDA records each applicant name separately; these may or may not be the same firm.